Santen NDA accepted for inflammatory eye disease drug

Japanese ophthalmology specialist Santen Pharmaceutical (TYO: 4536) has had its New Drug Application (NDA) accepted by the US Food and Drug Administration (FDA) for its intravitreal (IVT) sirolimus (DE-109), a potential treatment in non-infectious uveitis of the posterior segment (NIU-PS).

The FDA has set an action date of December 24, 2017 to complete its review of the IVT sirolimus NDA as per the Prescription Drug User Fee Act (PDUFA).

IVT sirolimus, an mTOR inhibitor, was granted orphan drug designation in the USA and Europe in 2011. The NDA is supported by data from the SAKURA program, the largest Phase III global clinical program to date evaluating patients with NIU-PS, a progressive and chronic inflammatory disease of the eye that can lead to vision impairment and blindness.